Cicaderma® in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT.

Abstract

To prevent the occurrence of grade≥2 radiodermatitis after post-operative breast irradiation in patients with non metastatic breast cancer. This prospective randomised open-label multicenter study allocated patients from 3 French institutions, ≥18years, requiring postoperative radiotherapy for histologically proven, early-stage (non-metastatic) unilateral breast adenocarcinoma or in situ breast cancer, with R0 or R1 post-operative status, to receive hygiene rules, associated with either Cicaderma® (Arm A), or preventive treatment according to the investigator preference (mainly hyaluronic acid (ialuset®), essential oils, or water spray, or no medication (Arm B). The primary outcome was to compare the efficacy of Cicaderma® versus local standard management in preventing the occurrence of grade≥2 radiodermatitis. Main secondary objectives include Cicaderma® impact on radiotherapy discontinuation and on skin toxicity (pruritus), pain, quality of life, satisfaction. The CICA-RT study enrolled from June 2020 to April 2021, 258 women with a median age of 61 (22-91) years in 3 institutions. Patients received either Cicaderma® (A: N=130) or standard practice (B: N=128). In the 123 patients who initiated radiotherapy in each arm, 95 (77%, 95%CI 68.8%-84.3%) patients did not develop grade≥2 dermatitis. Sensitivity and per-protocol analyses confirmed the absence of differences between arms. This prospective study did not meet its primary endpoint of superiority of Cicaderma® over routine practice skin care in terms of prevention of acute radioinduced dermatitis of grade 2 or higher. However, Cicaderma® showed a significant decrease in the occurrence of pruritus with less patients reporting at least once grade≥2 pruritus (A: N=38, 31%; B: N=58, 47%; p=0.009).ClinicalTrials.gov identifier NCT04300829.